Home India Ministry of Health and Family Welfare Parliament Question: Clinical Trials of Favipiravir...
Date: 2025-07-25 Category: Not Applicable State: Union Government Country: India

Parliament Question: Clinical Trials of Favipiravir

Issued by Ministry of Health and Family Welfare · Not Applicable

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Executive Summary & Key Takeaways

**Summary:** In response to a parliamentary inquiry regarding the use of Favipiravir for Chandipura virus (CHPV) treatment, the Ministry of Health and Family Welfare provides the following information: Preclinical studies by the ICMR-National Institute of Virology (ICMR-NIV), Pune, have demonstrated the antiviral effects of Favipiravir against CHPV. In vitro studies showed complete inhibition of CHPV growth at a concentration of 320µM Favipiravir. In vivo studies using Chandipura-infected CD1 mice showed that treatment with 300mg/kg/day of Favipiravir, administered orally for 7 days post-infection, resulted in 100% survival. The ICMR acknowledges that initiating clinical trials to prove Favipiravir's efficacy in humans is challenging due to the sporadic nature of Chandipura disease outbreaks. Current CHPV infection management protocols, as informed by AIIMS and ICMR, focus on early detection, supportive clinical care, and symptomatic treatment. This includes intravenous fluids, antipyretics, anticonvulsants, and measures to control cerebral edema, with ICU support as needed. Laboratory confirmation is conducted via RT-PCR and IgM ELISA. Surveillance and rapid case reporting are essential, alongside preventive measures such as vector control and promoting personal protection using repellents and insecticide-treated nets. The ICMR has initiated a multi-centric research initiative in collaboration with ICAR, NCDC, and the Gujarat State Health Department to investigate CHPV disease pathogenesis, transmission dynamics, and potential insect or animal reservoirs.

Key Entities Referenced

Favipiravir: An antiviral drug being studied as a potential treatment for Chandipura virus (CHPV). Chandipura virus CHPV: A virus for which Favipiravir is being investigated as a treatment. High fatality rate among children. National Institute of Virology NIV, Pune: An Indian research institute that conducted preclinical studies on Favipiravir and Chandipura virus (CHPV). Indian Council of Medical Research ICMR: An Indian organization that has informed about the pilot study to assess the antiviral activity of Favipiravir. AIIMS: An Indian medical institute involved in managing Chandipura virus infections. Indian Council of Agricultural Research ICAR: An Indian organization involved in a multicentric research initiative to investigate Chandipura virus. National Centre for Disease Control NCDC: An Indian organization involved in a multicentric research initiative to investigate Chandipura virus. Gujarat State Health Department: A state health department involved in a multicentric research initiative to investigate Chandipura virus.
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GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENT OFHEALTH RESEARCH LOK SABHA UNSTARRED QUESTION NO. 963 TO BE ANSWERED ON 25THJULY, 2025 CLINICALTRIALS OFFAVIPIRAVIR 963.DR. MALLU RAVI: Willthe Ministerof HEALTH ANDFAMILYWELFAREbe pleasedtostate: (a) whether the Government is aware of recent preclinical studies conducted by the National Institute of Virology (NIV), Puneregardingthe use of Favipiravir asa treatmentfor the Chandipura virus (CHPV); (b) if so, the outcomes of these studies in terms of viral suppression and survival benefits observed in animalmodels; (c) whether the Government proposes to initiate clinical trials of Favipiravir for human use in CHPV- affected regionsandif so, the detailsthereofalongwiththe timeline andresponsible agencies; (d) the current protocols for managing CHPVinfections inthe absence of a specific antiviral treatment; and (e) the support extended by the Government to fast-track research and drug development for CHPV, especiallyinlight of itshighfatalityrate amongchildren? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILYWELFARE (SHRIPRATAPRAO JADHAV) (a)and(b): Indian Council of Medical Research (ICMR) has informed that ICMR-National Institute of Virology (ICMR-NIV) Pune has conducted a pilot study to assess the antiviral activity of Favipiravir in Vero cells infected with Chandipura virus (CHPV) and demonstrated its antiviral effects. Complete inhibition of CHPV growth was observed at 320µM Favipiravir concentration. In addition, the antiviral effect of Favipiravir inChandipura infected CD1 mice was also demonstratedas allthe mice survived with the treatmentof 300mg/kg/day of Favipiravirgivenorallyfor 7 dayspost infection. (c): ICMR has informed that the clinical trials to prove efficacy are challenging because of sporadic occurrenceof Chandipura disease. (d): AIIMS and ICMR have informed that management primarily involves early detection, supportive clinical care, and symptomatic treatment. Hospitalized patients, especially children, are treated with intravenous fluids, antipyretics, anticonvulsants, and measures to control cerebral edema, including ICU support when necessary. Laboratoryconfirmation is done via RTPCR andIgM ELISA.Due tothe sporadic nature of outbreaks, surveillance and rapid case reporting are essential and being followed. Preventivemeasures focus on vector control and promoting personal protection through repellents and insecticide- treatednets. (e): Indian Council of Medical Research (ICMR) has undertaken a multicentric research initiative involving Indian Council of Agricultural Research (ICAR), National Centre for Disease Control (NCDC), andthe Gujarat StateHealthDepartment tocomprehensivelyinvestigate disease pathogenesis, transmission dynamics, andpotential insect or animalreservoirs. *****

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